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Comparison of satisfaction in dental treatments using patient-controlled sedation methods with midazolam, remimazolam, and dexmedetomidine

Not Applicable
Conditions
Diseases of the digestive system
Registration Number
KCT0008615
Lead Sponsor
Seoul National University Dental Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
90
Inclusion Criteria

? Patients aged 20 years or older and under 60 years old.
? Patients who meet the American Society of Anesthesiologists Physical Status (ASA PS) criteria of I or II.
? Patients with a body mass index (BMI) ranging from 18.5 to 30.
? Patients who have planned dental treatment under local anesthesia in oral and maxillofacial surgery and have given consent.
? Cases where dental treatment is expected to take place within 2 hours.
? Patients who have been informed about and consented to participate in a clinical trial on Patient-controlled sedation in dental anesthesia.

Exclusion Criteria

? Patients with hypersensitivity or allergies to sedatives or local anesthetics.
? Patients who are currently taking medications, such as analgesics, sedatives, psychiatric drugs, or any other medication that could potentially influence the results of the clinical trial.
? Patients classified as Mallampati III or IV.
? Patients who are pregnant or breastfeeding.
? Patients with liver, kidney, or brain function disorders.
? Patients with sleep apnea.
? Patients with Myasthenia gravis.
? Patients who are unable to read or understand the informed consent form.
? Other patients for whom the exclusion by the investigator is deemed necessary.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
evel of sedation (OAA/S - Observer's Assessment of Alertness/Sedation), Vital signs (blood pressure, heart rate, oxygen saturation), Pain level (NRS - Numeric Rating Scale);Bispectral Index (BIS), Number of times the button on the patient-controlled sedation device was pressed/Total amount of medication administered, Additional sedative dosage/administration frequency, Dosage of local anesthetic used;Anesthesiologist's/dentist's/patient's subjective satisfaction with patient-controlled sedation, Intraoperative memory assessment
Secondary Outcome Measures
NameTimeMethod
Demographic information, Height, Weight, Mallampati classification, Medical history, Dental anxiety scale, Sleep duration;Occurrence of adverse reactions
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